MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SMARTSITE¿ GRAVITY BURETTE SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10037032
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 20 bd alaris¿ smartsite¿ gravity burette sets came apart either while priming them with saline or during the infusion.The following information was provided by the initial reporter: "several incidents over the last few weeks where the bottom of the burrete disconnects during use.Some incidents have occurred during priming of the set whilst others have occurred during infusion of saline.The issue is that the bottom part of the burrette is falling off during priming.There has also been incidents where the bottom of the burrette has come apart during use (during infusion)".
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 20 bd alaris¿ smartsite¿ gravity burette sets came apart either while priming them with saline or during the infusion.The following information was provided by the initial reporter: "several incidents over the last few weeks where the bottom of the burrete disconnects during use.Some incidents have occurred during priming of the set whilst others have occurred during infusion of saline.The issue is that the bottom part of the burrette is falling off during priming.There has also been incidents where the bottom of the burrette has come apart during use (during infusion)".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for evaluation?: yes d.9.Returned to manufacturer on: 1/4/2022 d.4.Medical device lot #: 21109297 d.4.Medical device expiration date: 10/4/2024 h.4.Device manufacture date: 10/04/2021 h.6.Investigation: nine 10037032 samples were received without packaging for investigation, with residual fluid in the device.A visual inspection confirmed the customers experience as all of the samples were received with the bases detached and could not be securely reattached for functional leakage testing.Following a review of the manufacturing process, their analysis confirmed that the separation is most likely to have been caused by an insufficient amount of solvent having been applied to the base of the burette during the assembly process.This is a manually performed assembly step and is likely to have occurred due to human error.A review of the production records for lot 21109297 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.

• Brand Name: BD ALARIS¿ SMARTSITE¿ GRAVITY BURETTE SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13285051
• Report Number: 9616066-2021-52749
• Device Sequence Number: 12002858
• Product Code: FPA
• UDI-Device Identifier: 10885403244056
• UDI-Public: 10885403244056
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K780130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/04/2024
• Device Catalogue Number: 10037032
• Device Lot Number: 21109297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown